AIMS. To compare, in a "real world" setting, the efficacy and tolerability of two initial duloxetine starting doses: 30 mg once daily (q.d.) for 1 week, followed by escalation to 60 mg q.d. versus 60 mg q.d. without titolation, evaluating expecially the effects on sexual dysfunction.
Methods: The sample is constituted by outpatients meeting diagnostic criteria for mild-severe (HAMD17 > or =24 and CGI-S > or =4) Major Depressive Episode as defined by DSM-IV-TR (Diagnostic and Statistic Manual for Mental Disorder, Fourth Edition-Text Revision), based on the Structured Clinical Interview for DSM-IV-TR (Mini International Neuropsychiatric Interview, MINI). The study design planned an initial evaluation and 4 follow-up visits; at each visit the following scales were administered: Hamilton Rating Scale for Depression (HAMD17) and Anxiety (HAMA), Clinical Global Impression Severity Scale (CGI-S) for severity evaluation and Arizona Sexual Experience Scale (ASEX) for sexual disfunction evaluation.
Results: Both of the groups showed 90% of response (> or = 50% reduction in a patient's HAMD17 total score from baseline) within 2 months of follow-up. 50% of patients receiving a 30 mg q.d. starting dose achieved a HAMD17 total score < or =7 versus 40% of 60 mg q.d. treating group. None showed relapses during the study. After the first treatment month, the 60 mg q.d. receiving group showed a statistical significative amelioration of sexual function (Mann-Whitney test: p=0,02).
Conclusions: Our naturalistic "real world" study results confirm previous duloxetine tolerability and efficacy findings suggesting a 60 mg q.d. after meal duloxetine somministration without titolation.